Summary
Overview
Work History
Education
Skills
Certification
Interests
Timeline
Michelle Deakins, CPO

Michelle Deakins, CPO

Augusta,Kansas

Summary

Results-driven Quality Assurance Specialist with over 25 years of experience in client services, demonstrating a strong ability to prioritize tasks and multitask effectively. Known for exceptional communication and organizational skills, coupled with a steadfast commitment to meticulous reviews and auditing procedures. Passionate about continuous improvement and exploring innovative strategies to enhance team performance and operational efficiency. Consistently upholds high standards for quality in all contributions, ensuring excellence in every aspect of work.

Overview

18
18
years of professional experience
1
1
Certification

Work History

Quality Assurance Specialist

AMR Clinical
09.2023 - Current
  • Provide regular updates to team leadership on quality audits by communicating consistency problems or production deficiencies.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Coached and mentored staff at two start-up clinics to achieve full adherence to organizational quality protocols.
  • Collaborate with site management new and ongoing implementations of quality standards during the transitioning and rebuilding of two of the busiest clinics in the company.
  • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns.
  • Cultivate strong relationships with sites to ensure consistent quality and timely responses for sponsors/CRO's.
  • Inspected items and compared against standards to meet regulatory requirements.
  • Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
  • Assisted in the development and implementation of corrective and preventative measures to meet product quality standards.
  • Collected and analyzed data to measure effectiveness of quality control processes.
  • Reported problems and concerns to management.
  • Review test results by comparing to established specifications and control limits, confirming compliance with protocol requirements.
  • Conducts reviews, quality control inspections of source and internal audits to ensure compliance of protocol and standard practices to identify potential quality issues.
  • Investigates non-compliance and deviation root cause, for generating CAPA Plans for preventative measures while collaborating with the site staff and management.
  • Traveling onsite to assist site with preventative and corrective measures to proactively prevent reoccurrence.
  • Investigating and performing onsite internal audits to report non-compliance or potential causes of deviations proactively.
  • Vast awareness of company policies, regulations, SOPs, HIPPA, GDP, ALCOA+ and regulatory procedures.

Clinical Research Coordinator

AMR, LLC
02.2022 - 09.2024
  • Advised Investigator, Sub-Investigator and staff on protocols, procedures required for the successful implementation and completion of each clinical research study.
  • Familiarity with regulatory compliance and workflow processes.
  • Notified Investigator, monitor/CRA of any adverse events or serious adverse events per the protocol.
  • Maintained familiarity with each clinical research study’s requirements and apply all applicable regulations accurately.
  • Completed all required documentation in a legible and timely fashion.
  • Ensure all necessary documents are appropriately signed and dated.
  • Gathered, processed, and shipped lab specimens.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Followed informed consent processes and maintained records.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Ensured compliance with research protocols by providing ongoing quality control audits.

Optometric Technician

GRENE VISION GROUP
06.2021 - 02.2022
  • Data entry in NextGen electronic medical records data base
  • Assists Doctor with patient evaluation and data entry scripting
  • Report and verify medication changes
  • Research and compliance with all HIPPA regulations
  • Verify patient information by interviewing patient
  • Recording medical history, current medications and confirming purpose of visit
  • Meeting insurance coding and prior authorization for medications
  • Checks condition of patient's eyes by observing pupils, muscles, visual acuity, and extraocular movements
  • Required skills include: dilation, refraction, pressures, and performing a variety of diagnostic tests including visual fields, OCT, GDX, IOL master, auto refractor and topography, tonopen, Icare pen, Goldman IOP measuring
  • Teaching contact lens inserts and removals, calculating spherical equivalents and vertexing. Meeting goals on sales of contacts
  • Demonstrates working knowledge of eye anatomy, diseases, symptoms and ocular medications
  • General office duties and cleaning to be assigned by manager, scheduling and customer care
  • Keeping the patient engaged and comfortable with clinic practice and knowledgeable of their treatment

Certified Paraoptometric Technician

Ortiz Eye Associates
10.2013 - 06.2021
  • Assisting patients through eye pre-exam and treatments, DES treatments, visual acuities, fields and confrontations testing, depth perceptions, IOL Master Measurements for cataract surgeries, Fundus photos, Retinal imaging of Optic Nerve and macula, pachymetry, topography
  • Patient services, scheduling, demographic coordinations in office system as well as online Lens Ferry programs, pharmacy script transactions, optical frames and lens orders, HIPPA qualifications, collections
  • Assisting Doctors with invasive procedures on patients, sales, prescriptions, diagnostic instrument supplies
  • Connecting and leaving the patients with a professional and rewarding medical experience

Client Service Specialist

Medova Healthcare Financial Group, LLC
02.2008 - 03.2009
  • Customer Service, phones, sales, marketing and client services accumulating in sales gross between $40 to $50k annually
  • Responsible for managing dept of third party entity named, Direct Health, consisting of subsidiary health benefits coexisting with primary health insurance

Education

Some College (No Degree) - Bilingual studies in Spanish

Currently Seeking degree/credits toward Bilingual studies in Spanish

Certified Para Optometric (CPO) - Optometry

Optometric Association, Chicago, IL
10-2018

Associates Degree - General Studies

Friends University, Wichita, KS
01.2000
Credits toward Associates Degree in General Studies

Skills

  • Excellent Time and Multi-Tasking Management
  • Encouraging and Courteous listening and communication skills
  • Regulatory Filing and Organization
  • Excellent Company Standard Operating Procedures (SOP) Knowledge
  • ALCOA compliance expertise
  • Reliable assistance provider and team member
  • Proven track record of surpassing peer and patient expectations
  • HIPAA (15 years)
  • HIPAA Compliance Training to Date (15 years)
  • Customer service expertise
  • Medical Scheduling
  • Medical Office Experience
  • Customer service (25 years)
  • EMR Systems
  • Medical imaging
  • Medical Records
  • Microsoft Office
  • Administrative Experience
  • Microsoft Excel
  • Data entry

Certification

  • CPO
  • Certified Para Optometric
  • August 2018 - August 2027

Interests

  • Volunteering
  • Enjoy hobbies that combine physical activity with outdoor exploration like hiking or jogs
  • Gardening and Indoor Planting
  • Rehabilitating and creating safe havens to help populate both Monarch and Swallowtail Butterflies
  • Practicing restorative mindfulness, along with physical reset through frequent yoga practice, meditation and sound baths

Timeline

Quality Assurance Specialist - AMR Clinical
09.2023 - Current
Clinical Research Coordinator - AMR, LLC
02.2022 - 09.2024
Optometric Technician - GRENE VISION GROUP
06.2021 - 02.2022
Certified Paraoptometric Technician - Ortiz Eye Associates
10.2013 - 06.2021
Client Service Specialist - Medova Healthcare Financial Group, LLC
02.2008 - 03.2009
Friends University - Associates Degree, General Studies
- Some College (No Degree), Bilingual studies in Spanish
Optometric Association - Certified Para Optometric (CPO), Optometry

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